Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001454167p
Ethics application status
Submitted, not yet approved
Date submitted
25/09/2019
Date registered
21/10/2019
Date last updated
21/10/2019
Date data sharing statement initially provided
21/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
NAG: the Non-Adherence Gadget to motivate and remind children to follow their medical treatments
Scientific title
NAG: the Non-Adherence Gadget to motivate and remind children to follow their medical treatments
Secondary ID [1] 299411 0
nil known
Universal Trial Number (UTN)
U1111-1241-0223
Trial acronym
NAG
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Chronic kidney disease 314584 0
Chronic bladder problems 314668 0
Condition category
Condition code
Renal and Urogenital 312925 312925 0 0
Kidney disease
Renal and Urogenital 313008 313008 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
NAG, the Non-Adherence Gadget is an app that encourage adherence to treatment plans for young people with chronic health conditions. The paediatrician can add patients' treatments and parents can add the timing of notifications/alarms of when the treatment should be undertaken on the app. The app uses alarms to remind the child to follow the treatments and uses responses to the alarms to reward the child through a magical garden that grows as they adhere. When adherence is poor, NAG will initiate conversations between the child and an animated avatar that uses dialogue based on cognitive behaviour therapy and motivational interviewing.
In the intervention arm, patients will have access to the NAG app for 3 months. Participants have opportunities to interact with the app (such as responding to the alarm, choosing rewards, interacting with the avatar) but it will be up to the participant whether they wish to interact or not.
The conversations initiated by the avatar are designed by the clinicians in the research team (the psychologist and paediatrician) and are generic conversations around treatment adherence and barriers to following treatment with discussion of suggested solutions, based on cognitive behavioural therapy theories.
Poor adherence is when patients report never following the treatment advice.
The app analytics will be used to assess and monitor reported adherence.
Intervention code [1] 315660 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321524 0
Adherence to treatments as assessed by study specific questionnaire
Timepoint [1] 321524 0
3 months from when the link to the app is given to participants (who may choose to download or not download and use the app).
Secondary outcome [1] 375236 0
Quality of life as assessed by PedsQL
Timepoint [1] 375236 0
3 months from when the link to the app is given to participants (who may choose to download or not download and use the app).
Secondary outcome [2] 375396 0
Therapeutic alliance with avatar as assess by Working Alliance Inventory
Timepoint [2] 375396 0
3 months from when the link to the app is given to participants (who may choose to download or not download and use the app).
Secondary outcome [3] 375397 0
Usability and acceptability of the app as assessed by study specific questionnaire
Timepoint [3] 375397 0
3 months from when the link to the app is given to participants (who may choose to download or not download and use the app).
Secondary outcome [4] 375398 0
Usage of NAG by as assessed by NAG app analytics
Timepoint [4] 375398 0
3 months from when the link to the app is given to participants (who may choose to download or not download and use the app).
Secondary outcome [5] 375399 0
Health parameters as assessed by study specific questionnaire. This will be a free text response about improvements in the patient's health. The health parameters will depend on what interventions the patient was asked adhere to - for example if the patient was asked to take his antihypertensive medication regularly, the health parameter would be improvement in his BP.
Timepoint [5] 375399 0
3 months from when the link to the app is given to participants (who may choose to download or not download and use the app).
Secondary outcome [6] 375708 0
Adverse effects as assessed by study specific questionnaire. There are no known adverse events to using the NAG app but there may be some unintended adverse events which we will enquire about using a free text option
Timepoint [6] 375708 0
3 months from when the link to the app is given to participants (who may choose to download or not download and use the app).

Eligibility
Key inclusion criteria
Patients from the department of Nephrology aged 10 to 18 years who are non-adherent and who are judged to possibly benefit from the use of the NAG by their clinical team will be invited to participate in the pilot study.
Minimum age
10 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with severe/profound intellectual disability

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Qualitative analysis of patient response to the App and comparison of treatment adherence at the end of study compared with baseline.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2020
Actual
Date of last participant enrolment
Anticipated
31/01/2021
Actual
Date of last data collection
Anticipated
30/04/2021
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14866 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 28132 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 303915 0
Self funded/Unfunded
Name [1] 303915 0
Country [1] 303915 0
Primary sponsor type
University
Name
Macquarie University
Address
Department of Computing, Faculty of Science and Engineering, 4 Research Park Drive, Macquarie University. NSW. 2109.
Country
Australia
Secondary sponsor category [1] 304068 0
None
Name [1] 304068 0
Address [1] 304068 0
Country [1] 304068 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304419 0
Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 304419 0
The Children's Hospital at Westmead
Locked bag 4001
Westmead 2145
Ethics committee country [1] 304419 0
Australia
Date submitted for ethics approval [1] 304419 0
02/10/2019
Approval date [1] 304419 0
Ethics approval number [1] 304419 0

Summary
Brief summary
To use a child-friendly smartphone application (App), called NAG, the Non-Adherence Gadget which incorporates tailored reminders, rewards and cognitive behaviour therapy (CBT) to overcome psychosocial barriers to following treatment advice for patients with chronic health conditions (specifically kidney or bladder conditions). The research is a pilot study to determine whether the App is useful in improving treatment adherence and is acceptable to children, parents and doctors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96890 0
Prof Deborah Richards
Address 96890 0
Department of Computing
4 Research Park Drive
Macquarie University
North Ryde NSW 2109
Country 96890 0
Australia
Phone 96890 0
+61 2 9850 9567
Fax 96890 0
+ 61 2 9850 9551
Email 96890 0
[email protected]
Contact person for public queries
Name 96891 0
Prof Deborah Richards
Address 96891 0
Department of Computing
4 Research Park Drive
Macquarie University
North Ryde NSW 2109
Country 96891 0
Australia
Phone 96891 0
+61 2 9850 9567
Fax 96891 0
+61 2 9850 9551
Email 96891 0
[email protected]
Contact person for scientific queries
Name 96892 0
Prof Deborah Richards
Address 96892 0
Department of Computing
4 Research Park Drive
Macquarie University
North Ryde NSW 2109
Country 96892 0
Australia
Phone 96892 0
+61 2 9850 9567
Fax 96892 0
+61 2 9850 9551
Email 96892 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.